Developing and Using the Product Risk Management File/Report

Date:Wednesday, June 22, 2011
Time:10:00 AM PDT | 01:00 PM EDT
Live Webinar
Duration:90 Minutes
Developing and Using the Product Risk
Management File/Report
Price:$245.00

Why you should attend:


Register Now
The U.S. FDA has stated that the use of a medical device or
pharmaceuticals entails some degree of risk. In fact, any
medicalprocedure/interventiondoes.Amanufactureris
InstructorProfile:
responsible to identify those risks, and take reasonable steps
John E Lincoln
to mitigate them as far as practical and given the 'state of the
Consultant, Medical device
art' at the time. ISO 14971 and ICH Q9 provide accepted
and Regulatory Affairs
methodologies by which to perform and document such an
John E. Lincoln is a medical device
analysis and is accepted by the FDA. These activities can also
and regulatory affairs consultant. He
be used as a method to train new hires, especially in
has helped companies to implement
Marketing, QA/RA, Engineering, and Manufacturing. This
or modify their GMP systems and
webinar will address the procedures, provide and discuss
procedures, product risk
suggested templates, necessary to develop or modify and
management, U.S. FDA responses. In
then use the ISO 14971 and Q9 models to perform and
addition, he has successfully
document such activities for any medical product. It will
designed, written and run all types
examine the additional actions necessary to make it a useful
of process, equipment and software
product reference, CAPA, root cause / failure investigation,
qualifications/validations, which have
and validation prioritization, and training tool, and how to
passed FDA audit or submission
maintain it as a "living document".


scrutiny, and described in peer-
reviewed technical articles, and
Areas Covered in the Session:
workshops, world wide. John has
also managed pilot production,
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The Revised ISO 14971:2007 for Devices
regulatory affairs, product
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ICH Q9 for Pharma
development/design control, 510(k)
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Product Hazard Analysis
submissions, risk management per
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Design, Process, and Use[r] Failure Mode, Effects and
ISO 14971, and projects; with over
Criticality Analysis
28 years of experience in the FDA-
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Fault Tree Analysis
regulated medical products industry -
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Suggested Risk Management File / Report, FMECA, FTA
working with start-ups to Fortune
Templates
100 companies, including Abbott
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The Team and Its Involvement - Who, When and How
Laboratories, Hospira,
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Using the Completed Document - It's Real Value "In the
Tyco/Mallinckrodt. He is a graduate
Loop"
of UCLA. ...more


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Who Will Benefit:
Your Necessity is our Priority

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Senior management in Drugs, Devices, Biologics,
Dietary Supplements
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QA
l
RA
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R&D
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Engineering
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Production
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Operations
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Consultants; others tasked with project leadership
responsibilities
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit
from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
Best regards,
Event-coordinator
GlobalCompliancePanel
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